MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK; GMK-SPHERE RESURFACING PATELLA E-CROSS ¿ S1

Model Number	02.12.E001RP
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	10/20/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
11 months after the primary surgery, the patient presented with patellar tracking issues of unknown cause.The surgeon revised the patellar component and replaced the liner per standard procedure.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 03 november 2025 lot 2400498: (b)(4) items manufactured and released on 28-march-2024.Expiration date: 05-march-2029.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported events during the period of review.Root cause: based on the available information, no definitive root cause can be established.There is no indication that any potential issue with the device may have caused or contributed to the event, and the device history record review does not indicate any potential manufacturing-related issues.

• Brand Name: GMK
• Common Device Name: GMK-SPHERE RESURFACING PATELLA E-CROSS ¿ S1
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro 6874 ; SZ 6874
• Manufacturer Contact: marco giannessi ; strada regina; castel san pietro 6874 ; SZ 6874
• MDR Report Key: 23510645
• Report Number: 3005180920-2025-01119
• Device Sequence Number: 18611307
• Product Code: JWH
• UDI-Device Identifier: 07630971260979
• UDI-Public: 07630971260979
• Combination Product (Y/N): N
• PMA/510(K) Number: K202022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/10/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 02.12.E001RP
• Device Lot Number: 2400498
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/22/2025
• Initial Report FDA Received Date: 11/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/28/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female